FDA will hold a public hearing on a “new paradigm” for drug approvals that “under conditions of safe use” will allow nonprescription access to some categories of Rx drugs for treating chronic conditions.
FDA Digs Deeper On “New Paradigm” To Expand Rx Switches
The questions FDA poses for a March 22-23 hearing indicate the agency is delving into greater detail than in its previous discussions of alternative routes to access pharmaceutical treatments. FDA says decisions would be made case by case, but refers to treating conditions including high cholesterol, high blood pressure, migraines and asthma.
More from United States
The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.
More from North America
The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration.
Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.